UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014936 |
|---|---|
| Receipt number | R000017379 |
| Scientific Title | The Nationwide Survey of Pulmonary Nontuberculous Mycobacteria in Japan |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2014/08/24 13:04:45 |
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Basic information
Public title
The Nationwide Survey of Pulmonary Nontuberculous Mycobacteria in Japan
Acronym
The Nationwide Survey of Pulmonary NTM in Japan
Scientific Title
The Nationwide Survey of Pulmonary Nontuberculous Mycobacteria in Japan
Scientific Title:Acronym
The Nationwide Survey of Pulmonary NTM in Japan
Region
| Japan |
Condition
Condition
Pulmonary Nontuberculous Mycobacteria
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the incidence rate of Pulmonary Nontuberculous Mycobacteria in Japan
Basic objectives2
Others
Basic objectives -Others
To compare with the incidence rate of tuberculosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence rate of Pulmonary Nontuberculous Mycobacteria
Key secondary outcomes
The distribution of Pulmonary Nontuberculous Mycobacteria
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of pulmonary nontuberculous mycobacteria who were diagnosed by the diagnosis criteria of JSTB/JRS in 2008
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Mitarai |
Organization
The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association
Division name
Department of Mycobacterium Reference and Research,
Zip code
Address
3-1-24 Matsuyama Kiyose Tokyo
TEL
042-493-5711
mitarai@jata.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ho Namkoong |
Organization
Keio University School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
35 Shinanomachi Shinjyuku Tokyo Japan
TEL
03-3353-1211
Homepage URL
hounamugun@gmail.com
Sponsor or person
Institute
The Study Group of Epidemiology, Diagnosis and Treatment of Nontuberculous Mycobacteria
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
To schedule to announce the analyzed results on the web
Management information
Registered date
| 2014 | Year | 08 | Month | 24 | Day |
Last modified on
| 2014 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017379
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
